What is NDC 76168-501?

76168-501 is the product NDC for Allergy Relief 24HR (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by VELOCITY PHARMA LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Allergy Relief 24HR (Levocetirizine dihydrochloride).

What is the active ingredient?

Levocetirizine dihydrochloride.

VELOCITY PHARMA LLC, NDC labeler code 76168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Allergy Relief 24HR?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Allergy Relief 24HR NDC 76168-501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76168-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76168-0501Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
76168-501-10	76168050110	1 BOTTLE in 1 CARTON (76168-501-10) / 10 TABLET in 1 BOTTLEMarketed from Jul 2, 2019
76168-501-11	76168050111	1 BOTTLE in 1 CARTON (76168-501-11) / 100 TABLET in 1 BOTTLEMarketed from Dec 13, 2019
76168-501-18	76168050118	1 BOTTLE in 1 CARTON (76168-501-18) / 180 TABLET in 1 BOTTLEMarketed from Dec 13, 2019
76168-501-24	76168050124	1 BOTTLE in 1 CARTON (76168-501-24) / 240 TABLET in 1 BOTTLEMarketed from Dec 13, 2019
76168-501-36	76168050136	1 BOTTLE in 1 CARTON (76168-501-36) / 360 TABLET in 1 BOTTLEMarketed from Jul 2, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Allergy Relief 24HR
Generic name (nonproprietary): levocetirizine dihydrochloride
Active ingredients: Levocetirizine dihydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: VELOCITY PHARMA LLCNDC labeler code 76168
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211551
Marketing start: Jul 2, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76168-501_259de08e-0294-07bb-e063-6294a90a66cbSPL ID 259de08e-0294-07bb-e063-6294a90a66cbSPL set ID 8ba208dc-34fe-453a-8658-ed4f232e1a94RxCUI 855172UNII SOD6A38AGA
Pharmacologic class: Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476168050110 followed by a unit qualifier and the quantity

Package 76168-0501-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 29, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76168-501

What is NDC 76168-501?: 76168-501 is the product NDC for Allergy Relief 24HR (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by VELOCITY PHARMA LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Allergy Relief 24HR (Levocetirizine dihydrochloride).
What is the active ingredient?: Levocetirizine dihydrochloride.
Who is the labeler?: VELOCITY PHARMA LLC, NDC labeler code 76168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy Relief 24HR?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 211551

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211551
Product	Strength	Form · route	Labeler	Product NDC
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Micro Labs Limited	42571-312

Allergy Relief 24HR (Levocetirizine dihydrochloride) NDC 76168-501